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Balancing risks: making decisions for maternal treatment without data on fetal safety
Howard Minkoff1, Jeffrey Ecker2
1Department of Obstetrics and Gynecology, Maimonides Medical Center, Brooklyn, NY; Department of Obstetrics and Gynecology, School of Public Health, SUNY Downstate Health Sciences University Brooklyn, NY.
American Journal of Obstetrics and Gynecology
|February 4, 2021
Summary
Pregnant individuals should have access to new treatments, like the COVID-19 vaccine, with their decisions respected. Including pregnant people in clinical trials is crucial for ethical decision-making and avoiding health dilemmas.
Area of Science:
- Medical Ethics
- Obstetrics
- Clinical Trials
Background:
- Maternal health treatments can pose risks to fetal health, a dilemma highlighted by the COVID-19 vaccine.
- Pregnant patients are often excluded from clinical trials, creating data gaps for new therapies.
- Balancing maternal autonomy and fetal protection is a significant ethical challenge for healthcare providers.
Purpose of the Study:
- To examine the ethical considerations of providing new treatments to pregnant patients, using the COVID-19 vaccine as an example.
- To advocate for pregnant individuals' right to access new therapeutic agents and support their treatment decisions.
- To propose including pregnant individuals in clinical trials as a solution to data scarcity and ethical dilemmas.
Main Methods:
- Ethical analysis of obligations to pregnant patients versus fetal protection.
- Review of legal precedents and historical events (e.g., thalidomide) impacting reproductive health decisions.
- Emphasis on shared decision-making between patients and physicians.
Main Results:
- In most cases, maternal benefit and patient autonomy should guide decisions regarding new treatments, even with limited safety data.
- Excluding pregnant individuals from trials creates ethical quandaries and denies them potential benefits.
- Ethical frameworks suggest that sacrificing maternal health for potential fetal benefit is not a mandate.
Conclusions:
- Pregnant patients should be offered new treatments, such as the COVID-19 vaccine, and their autonomous decisions should be supported.
- Including pregnant individuals in clinical trials is essential for generating data and resolving ethical dilemmas.
- Shared decision-making, respecting patient values, is paramount in navigating complex maternal-fetal health choices.
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